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The purpose of this study is to investigate the efficacy and safety of the lifileucel regimen in participants with previously treated endometrial cancer.
The study will enroll participants with advanced endometrial cancer who previously received treatment with platinum-based chemotherapy and an anti-programmed cell death protein-1 (PD-1)/programmed death ligand 1 (PD-L1) agent in a recurrent or advanced setting, either sequentially or in combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Endometrial Cancer | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifileucel | Biological | A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepleting chemotherapy including cyclophosphamide and fludarabine, participant is infused with lifileucel, followed by IL-2. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | To evaluate the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1. | Up to 5 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate | To evaluate the proportion of participants who have a confirmed complete response (CR) per RECIST v1.1. | Up to 5 Years |
| Duration of Response | To measure from the first time that criteria are met for complete response (CR) or partial response (PR) per RECIST v1.1. |
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Inclusion Criteria:
Participants must have a histologically confirmed diagnosis of endometrial carcinoma. All histologies, including carcinosarcoma, will be allowed. Uterine sarcoma will not be allowed.
Participants who have received the following previous therapies:
Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and estimated life expectancy of >6 months.
Participants having at least one resectable lesion and at least one measurable lesion, following resection of the lesion for TIL generation.
Participants who have adequate organ function, including adequate cardiopulmonary function.
Participants of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months after the last dose of study intervention.
Participants who are >70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Iovance Biotherapeutics Study Team | Contact | 1-844-845-4682 | Clinical.Inquiries@iovance.com |
| Name | Affiliation | Role |
|---|---|---|
| Iovance Biotherapeutics Study Team | Iovance Biotherapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Honor Health | Recruiting | Phoenix | Arizona | 85016 | United States | |
| University of Southern California |
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|
|
| Up to 5 Years |
| Disease Control Rate | To measure by the percentage of participants with best overall confirmed response of complete response (CR) or partial response (PR) at any time or stable disease (SD) for at least 4 weeks per RICIST v1.1. | Up to 5 Years |
| Progression-Free Survival | To evaluate the time from the date of the lifileucel infusion until disease progression per RECIST v1.1. | Up to 5 Years |
| Overall Survival | To measure the time from the date of lifileucel infusion to death due to any cause. | Up to 5 Years |
| Adverse Events | To characterize the safety and tolerability profile of lifileucel in participants with advanced endometrial cancer. | Up to 5 Years |
| Recruiting |
| Los Angeles |
| California |
| 90007 |
| United States |
| Orlando Health | Recruiting | Orlando | Florida | 32806 | United States |
| H. Lee Moffitt Cancer Center and Research Institute, Inc. | Recruiting | Tampa | Florida | 33612 | United States |
| Augusta University | Recruiting | Augusta | Georgia | 30912 | United States |
| UofL Health - Brown Cancer Center | Recruiting | Louisville | Kentucky | 40202 | United States |
| Barbara Ann Karmanos Cancer Hospital | Recruiting | Detroit | Michigan | 48201 | United States |
| Roswell Park Cancer Institute | Recruiting | Buffalo | New York | 14203 | United States |
| University of Oklahoma | Recruiting | Oklahoma City | Oklahoma | 73117 | United States |
| Allegheny Health | Recruiting | Pittsburgh | Pennsylvania | 15524 | United States |
| Avera Medical Group Oncology | Recruiting | Sioux Falls | South Dakota | 57105 | United States |
| MD Anderson Cancer Center - U of Texas | Recruiting | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C000730287 | lifileucel |
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